Recently the Supreme Court of India rejected Novartis's appeal for Glivec patent protection stating that an "incremental innovation" is not protected under Section 3 (d) of Indian Patent Act, 1970 (hereinafter "the Act"). This judgment has compelled the pharmaceutical companies to rethink their move towards research and development (R&D) and to obtain patents in India. Our patent regime does not encourage or support the patenting of incremental innovations. Incremental Pharmaceutical Innovations (hereinafter "IPIs") have been stayed behind the economic growth and success of Indian pharmaceutical companies. Generally IPIs results in enhancement of the safety, efficiency of existing drugs and thus improving the quality of life of patients. Indefinite expression of section 3(d) of the Act limits the patentability of incremental innovation. Hence, amendment in section 3(d) of the Act is the need of the hour in order to bring some transparency in the patent regulation relating to pharmaceutical innovations. A patent system that generates spur to the incremental innovations can lead to cost decline and boost up the access to medicines by motivating the investment into domestic pharmaceutical research.
SECTION 3(D) AND INCREMENTAL PHARMACEUTICAL INNOVATION
Under Section 3(d) of the Act, incremental pharmaceutical innovations—including new forms of known pharmaceutical substances—are not patentable unless they result in significantly enhanced "efficacy" of the active substance. The new invention must fulfill the patentability criteria i.e. novelty, inventive step and industrial applicability, in order to get a patent in India. Most of the incremental innovations satisfy the patentability criteria but still be unable to get patent because of the enhanced efficacy criteria set out by section 3(d). Thus majority of the IPIs are excluded by reducing the scope of patentability to only new forms of known substances and their derivatives which differ significantly in properties with respect to efficacy. The works "efficacy" and "significantly" used in section 3(d) are neither defined in the Act nor anywhere else in the guidelines to that effect. Therefore the manufactures/ inventors does not have any resource for knowing the required standard for patentability of the incremental innovation. More over pharmaceutical companies find it very hard to provide clinical data to demonstrate the therapeutic efficacy of the new form or new use of the drugs in the preliminary stages of drug development. It is obvious that present regime under section 3(d) is not favorable to incremental pharmaceutical innovation. Inconsistency in the wording of section 3(d) has to be resolved by including new use of a new form as patentable subject matter.
Section 3(d) is limiting the eligibility of incremental pharmaceutical innovations and resulting in discouragement in R&D for new routes of dose administration, new dosage forms, and other innovations that would result in the development of drug products that are well-suited to the needs of Indian patients.
DISTINCTION BETWEEN RADICAL AND INCREMENTAL PHARMACEUTICAL INNOVATION
Pharmaceutical innovations are of two types Radical and Incremental innovation. The former represents a separate new class of drugs which are having a novel mode of action, the latter also represents new drugs but in an already existing class, which have a similar mechanism as the first ones, however the incremental innovations differ in features such as, therapeutic profile, metabolism, adverse effects, dosing schedules, delivery systems, etc. While radical innovations are uniformly protected in all patent regimes, incremental innovation is generally regarded not worthy of protection because of the prevailing notion that they represent nothing more than the copies of existing molecules.
IPIs involve discovery of new forms and uses of known chemical compounds or substances, which results in to the safer, more effective and more useful drugs that are better suited to particular patient profiles and result in to improve patient compliance and greater overall wellbeing. Thousands of smaller incremental innovations set the basis upon which "blockbuster" drugs are originated. Discovery of penicillin is a good illustration of a radical pharmaceutical innovation that gave birth to potent new cure for bacterial diseases and instigated a new field of pharmaceutical research on antibiotics. US National Research Council has recognized that the cumulative effect of numerous minor incremental innovations can sometimes be more transformative and have more economic impact than a few radical innovations or technological break through1.
IMPORTANCE OF PROTECTING INCREMENTAL INNOVATION
1. Clinical value of Incremental Pharmaceutical Innovation (IPI)
A study conducted in 2007 of the medicines on the WHO's Essential Drug List, found that over 60% of the drugs on the list reflect incremental Improvements of older drugs2. Incremental pharmaceutical innovation has the following clinical values:
- Increased effectiveness, extended usefulness, and greater selectivity over prior known drug products;
- Breakthrough drugs normally have side-effects and other restrictions, which are replaced by more effective incrementally improved versions;
- Eradication or reduction of a treatment-limiting drug reaction;
- Evidence of safety and effectiveness for a new patient subpopulation.
- Increased effectiveness often is the result of incremental advances in dose delivery systems and dosage forms, such as transdermal delivery and extended release formulations, which can optimize the rate of absorption of a molecule and thereby maximize its therapeutic effect, while reducing toxicity and side-effects3.
- More convenient dosing schedules which improve patient compliance.
2. Public Health & Socio-Economic implications: Improving quality life of Patients
The incremental pharmaceuticals innovations do have some prominent positive implications on the public health and our socio-economic conditions. Some of them are as below:
- IPIs increases the numbers of different drugs in a specific class, thereby increases the price competition among those drugs and ultimately leading to drug price reduction. Thus this will make the drugs accessible to each and every section of the society.
- Reduction in the overall cost of healthcare by improving the quality and selection of drugs available to the patients.
- Boost the completion in the pharmaceutical industry leading to more research and development and new and better products to the consumers;
- Increases revenue from incremental innovation which can be used to support the research & development of "blockbuster drugs"
- New formulations and drug delivery systems specially developed which are specifically suited to Indian climate. For instance, use of microspheres for the controlled release of vaccines which make them resistant to extreme heat conditions could greatly help people living in remote areas of India where there is no refrigeration4.
- Mashelkar Committee has also suggested that discouragement of incremental innovation could dissuade both Indian and foreign investors from investing in India5.
Incremental pharmaceutical innovation provides great support to the pharma companies to boost up research and development of the new drugs by offering opportunities to make profits by advancing the existing drugs. Consequently, elimination of incremental innovations from patent protection would cut the encouragement to modify the existing drugs and finally would affect the financial sources for new drug discovery. Incremental innovations also serve to enhance the safety and efficiency of existing drugs thereby improving the quality of life of patients. Indefinite wording of section 3(d) makes the patentability requirements for incremental innovation highly uncertain. Section 3(d) also acts as a disincentive for Indian pharmaceutical companies, who might otherwise capitalize on the economic opportunities presented by incremental pharmaceutical innovations in India and abroad.
2 J. Cohen et al., The role of follow-on drugs and indications on the WHO Essential 12 Drug List, 31 JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS 6,(2006)
3 See 20 Albert Wertheimer & Thomas Santella, "Pharmacoevolution: the advantages of incremental innovation," IPN Working Papers on Intellectual Property, Innovation and Health, International Policy Network (2005), at 8.
5 Report of the Technical Expert Group on Patent Law Issues, March, 2009, available at www.ipindia.nic.in/RevisedReport_March2009.doc
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